Johnson & Johnson Surgical Vision Inc: Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure.

Is my product affected?

Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The product provides the item necessary to perform one vitrectomy procedure. It is used to remove vitreous from the eye. It has been designed as a disposable (single use)

• UPC 05050474534117

Check against the official notice below — it lists the full affected range.

What happened

Johnson & Johnson Surgical Vision Inc. is recalling 392 units of Disposable 25GA Vitrectomy Cutters (model NGP0025) due to a packaging error where 20GA Vitrectomy Cutters may be found in 25GA packages. These single-use surgical instruments are used to perform vitrectomy procedures. The affected lot (Lot Number 60084881, manufactured September 5, 2017, expiring September 5, 2020) was distributed across multiple U.S. states including North Carolina, Nevada, Texas, New York, Utah, California, Minnesota, Washington, New Jersey, and Ohio, as well as internationally to Australia and Japan.

Use of a vitrectomy cutter that is a different gauge than expected could require surgeons to alter their surgical technique, potentially including enlargement of the corneal incision. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement.

Details from the source

Reason for recall: Packaging error, 20GA Vitrectomy Cutter may be found in a 25GA package. Use of a Vitrectomy cutter that is a different size than expected could lead to the need to alter the surgical technique, including corneal incision enlargement. Distribution: US Distribution to states of: NC, NV, TX, NY, UT, C, MN, NY, WA, NJ, OH, NV, CA and Internationally to: Australia and Japan. Quantity: 392 units Lot/code info: Lot Number: 60084881 Mfg. date: 2017-09-05 Exp. date: 2020-09-05 UDI: (01)05050474534117 (17)200905(10)60084881

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.03882018-09-24
• StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733062018-09-26
• StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by inj2018-09-21
• Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL M2018-09-28
• Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 2018-09-17

All FDA (Device enforcement) recalls